Mesoblast Limited (MESO)'s Ryoncil Gains U.S.-Origin Status, Avoids Import Tariffs

We recently compiled a list of the 12 Healthcare Stocks with Insider Buying in 2025. Mesoblast Limited is one of them.

Mesoblast Limited (NASDAQ:MESO) is a global leader in developing allogeneic, off-the-shelf cellular medicines for inflammatory diseases. Using its proprietary mesenchymal lineage cell platform, the company targets severe and life-threatening conditions by modulating immune responses and promoting tissue repair. Its lead product, Ryoncil® (remestemcel-L), recently became the first FDA-approved allogeneic mesenchymal stromal cell therapy for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD). MESO is among the stocks with insider buying.

In late September 2025, Mesoblast Limited (NASDAQ:MESO) reaffirmed that all its cell therapy products, including Ryoncil®, are manufactured from U.S. donors in the United States and officially designated as U.S.-origin products. This designation exempts them from pharmaceutical import tariffs, giving the firm a significant commercial edge while underscoring its commitment to U.S.-based manufacturing and regulatory compliance.

Looking ahead, MESO is advancing the commercial launch of Ryoncil® while also progressing regulatory pathways for other therapies. Its Biologic License Application for Revascor®, aimed at treating ischemic heart failure, is under FDA review. At the same time, the business is expanding the development of rexlemestrocel-L for chronic conditions such as heart failure and low back pain.

While we acknowledge the potential of MESO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

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Disclosure: None.